Zura Bio has initiated a randomized Phase II clinical trial evaluating tibulizumab for the treatment of moderate to severe hidradenitis suppurativa (HS), an inflammatory skin disease also known as acne inversa.
The TibuSHIELD trial marks the first study to assess dual inhibition of the B-cell activating factor (BAFF) and interleukin-17A (IL-17A) pathways in HS patients. This global, double-blind, placebo-controlled study will enroll approximately 180 adult participants across sites in the United States, Canada, and Europe.
"The initiation of TibuSHIELD marks a key milestone in our mission to advance potentially differentiated therapies for patients with severe inflammatory diseases," said Kiran Nistala, Chief Medical Officer and head of development at Zura Bio. "We remain committed to advancing clinical development with investigators, clinical sites, and the HS community."
Trial Design and Endpoints
The TibuSHIELD study will monitor patients over a 28-week period, which includes a 16-week primary efficacy evaluation followed by a 12-week safety follow-up. Participants will also have the option to continue treatment in an open-label extension phase.
Subjects will be randomized 1:1:1 to receive one of two different doses of tibulizumab or placebo. The primary endpoint is the percentage change from baseline in total abscess and nodule (AN) count at week 16. Secondary endpoints will assess the proportion of participants achieving significant reductions in AN count without an increase in abscesses or draining fistulas at the same timepoint.
The trial will also include comprehensive safety evaluations, focusing on tolerability and monitoring for adverse events. Topline results for the primary efficacy endpoint are expected in the third quarter of 2026.
About Tibulizumab
Tibulizumab represents an innovative approach to treating inflammatory conditions. It is a humanized dual-antagonist antibody designed by fusing Taltz (ixekizumab) and tabalumab to simultaneously bind and neutralize IL-17A and BAFF.
This novel mechanism of action could potentially offer advantages over current treatments for hidradenitis suppurativa, which remains a challenging condition to manage effectively. The TibuSHIELD trial follows the December 2023 initiation of the TibuSURE trial, which is evaluating tibulizumab in adults with systemic sclerosis.
Hidradenitis Suppurativa: An Unmet Medical Need
Hidradenitis suppurativa is a chronic, debilitating inflammatory skin disease characterized by painful nodules, abscesses, and tunnels (sinus tracts) that typically develop in areas where skin rubs together, such as the armpits, groin, and under the breasts.
The condition significantly impacts patients' quality of life, causing physical pain, scarring, and often psychological distress due to its visible and painful manifestations. Current treatment options for moderate to severe HS are limited, highlighting the need for novel therapeutic approaches like tibulizumab.
By targeting both the BAFF and IL-17A pathways, Zura Bio aims to address the complex inflammatory processes underlying HS pathogenesis. The TibuSHIELD trial represents an important step forward in the development of potential new treatment options for patients suffering from this challenging condition.
